Bright Element Sdn Bhd
⚠️ Moderate Risk
FEI: 3005748439 • Selangor Darul Ehsan • MALAYSIA
FEI Number
3005748439
Location
Selangor Darul Ehsan
Country
MALAYSIAAddress
Lot 5987, Off Jazlan Meru, 5 Jalan Teratai Batu, Klang, Selangor Darul Ehsan, , Malaysia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
Frequently Asked Questions
What is Bright Element Sdn Bhd's FDA import refusal history?
Bright Element Sdn Bhd (FEI: 3005748439) has 2 FDA import refusal record(s) in our database, spanning from 5/14/2009 to 5/29/2012.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Bright Element Sdn Bhd's FEI number is 3005748439.
What types of violations has Bright Element Sdn Bhd received?
Bright Element Sdn Bhd has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Bright Element Sdn Bhd come from?
All FDA import refusal data for Bright Element Sdn Bhd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.